Top Back to top

Data Collection

The EBMT requests from all member centres that all patients undergoing an HSCT, treatment for aplastic anaemia, or any other type of cellular therapy be registered in the EBMT Registry.  This can be done by submitting a set of EBMT data collection forms, preferably completed Med-B forms. If this is not possible, the centre should submit completed Med-A forms. A document with instructions on how to submit data to the EBMT is available below. 

Questions must be read carefully before completing. Titles and subtitles provide information on when certain questions should be filled in. If the information requested in the MED-AB paper forms is unavailable because it has not been evaluated or because it is definitely unknown, this must be clearly stated, thus preventing the EBMT data managers from having to ask this question again. Note that the information requested in the MED-A form -and its equivalent in the MED-B forms- is mandatory and cannot be "unavailable" as it constitutes the minimum essential data. Transplants cannot be performed without it being available.

Centres should also download and fill in the Patient Consent form below for each of their patients, or they may use their own, as the law requires that the patient consents to the data being transferred to the EBMT. In addition, if the centre intends to forward data, either directly or through the EBMT, to countries located outside the EU/EEA, they must ensure this is explicitly stated in the patient consent form. It is the centre’s responsibility to ensure that the patient has consented before data is forwarded to the EBMT.

Instructions & Consent Form

Document Download
Submitting Data to the EBMT Registry Download Submitting Data to the EBMT Registry
Instructions on how to enter informed consent data into ProMISe for new patients Download Consent Form for Data Registration with the EBMT
Instructions on how to add informed consent data in ProMISe for already registered patients Instructions on how to enter informed consent data for patients registered in ProMISe
Instructions on how to enter minimal essential data for non-consenting patients in ProMISe Instructions on how to enter minimal essential data for non-consenting patients in ProMISe
HSCT Forms

HSCT Registrations

The EBMT produces detailed disease-specific and HSCT-specific forms called MED-B.

A disease-specific MED-B consists of an initial information sheet common to all diseases and procedures, a detailed disease-specific pre-HSCT section detailing the diagnosis and pre-HSCT treatment, and a follow-up section detailing complications and events that happened after the HSCT. The above is complemented with two HSCT-specific MED-B forms: Allograft and Auto​graft​​​.

All registrations must include a disease-specific form and an HSCT-specific form. The follow-up section of each disease-specific form should be submitted yearly. Although not mandatory, the MED-B forms are the basis for all registry-based scientific studies performed within the Working Parties, and the EBMT encourages all centres to complete them.

The MED-A  form contains what is considered the Minimum Essential Data. It is mandatory that these data be submitted for all patients. The First Report consists of a common set of data that allows registration of the patient, the disease-specific data and a summary of the procedures at day 0, then the remaining post-transplant information at 100 days. The Follow-up Report consists of a data set common to all diseases and procedures that allows complications and events taking place after the procedure to be registered. For follow-up intervals, please see the guidelines on the Data Submission page.

The submission of MED-A data is a requirement for a centre to hold full membership in the EBMT, but as the MED-A data are part of the MED-B forms, if MED-B forms are submitted, it is not necessary to submit a MED-A in addition.

The document "MED-AB Forms Manual", which details the definition of individual MED-AB items, has been written to help with the completion of these forms. This is a very extensive document and it is meant to be consulted online, as additions and corrections are frequent. 

 

Cellular therapy forms

Cellular Therapy (non-HSCT Registrations)

The Cellular Therapy Registry (CTR) aims to collect data on stem cells, progenitors or mature cells, such as T-lymphocytes, unmanipulated, such as DLI, or sorted and/or cultured and/or genetically manipulated, such as CAR-T cells, used for treatment in combination with hematopoietic stem cell transplantation or alone, and including advanced therapeutic medicinal products (ATMP), as well as data on the clinical characteristics and outcomes of the patients.

The form also collects details of laboratory manipulation for all types of cells before they are infused into the patient. They include: selection, modification, genetic engineering and others.

A manual ​on how to complete the forms is also available in the Cellular Therapy forms section.

 

Donor Outcome forms

Donor Outcome

While donor characteristics and collection procedures have undergone major changes, donor safety remains a vital issue and is the basis for sustained high motivation in donors. To ensure maximum donor safety and availability, information on short- and long-term donor outcome is important. 

For this purpose, Donor Outcome forms have been implemented under the guidance of the EBMT Donor Outcome Committee and in collaboration with the Swiss Transfusion SRC. It consists of two forms, one for the collection procedure and one for follow-up. A manual on how to complete the forms is also available. Join us in this very important exercise by completing these forms regularly. 

 

Clinical manuals

Help with form completion

For help filling out the forms, please refer to the manuals, which are designed to help with the submission of specific data collection forms. 

If any doubts arise as to how to complete the forms which cannot be resolved by reading the relevant manuals, they should be addressed to the national registry or EBMT Registry, which will ensure expert advice is sought in each case. It is very important that the people filling in these forms do point out ambiguities, lack of clarity, etc. Any criticism can only improve the forms and manuals.

 

HSCT MED-A Forms

You can download separate MED-A forms by diagnosis and graft type below. Alternatively, you can download the full version.

MED-A Day 0 by Diagnosis and Graft type

Diagnosis autograft allograft
Acute Leukaemias - Acute Myeloid Leukaemia (AML) Download AML Day 0 Autograft MED-A Form Download AML Day 0 Allograft MED-A Form
Acute Leukaemias - Precursor Lymphoid Neoplasms (PLN) Download PLN Day 0 Autograft MED-A Form Download PLN Day 0 Allograft MED-A Form
Acute Leukaemias - Other acute leukaemias Download Other ALs Day 0 Autograft MED-A Form Download Other ALs Day 0 Allograft MED-A Form
Autoimmune Diseases Download Autoimmune Diseases Day 0 Autograft MED-A Form Download Autoimmune Diseases Day 0 Allograft MED-A Form
Bone Marrow Failure inc Aplastic Anaemia and Haemoglobinopathy Download AA Haemoglobinopathy Day 0 Autograft MED-A Form Download AA Haemoglobinopathy Day 0 Allograft MED-A Form
Chronic Leukaemias - Chronic Myeloid Leukaemia (CML) Download CML Day 0 Autograft MED-A Form Download CML Day 0 Allograft MED-A Form
Chronic Leukaemias - Chronic Lymphocytic Leukaemia (CLL) Download CLL Day 0 Autograft MED-A Form Download CLL Day 0 Allograft MED-A Form
Chronic Leukaemias - Prolymphocytic Leukaemia (PLL) / Other leukaemias Download PLL Day 0 Autograft MED-A Form Download PLL Day 0 Allograft MED-A Form
Inherited Disorders Download Inherited Disorders Day 0 Autograft MED-A Form Download Inherited Disorders Day 0 Allograft MED-A Form
Lymphomas - Hodgkins Download Hodgkin Day 0 Autograft MED-A Form Download Hodgkin Day 0 Allograft MED-A Form
Lymphomas - B-cell Non Hodgkins (NHL) Download NHL B-Cell Day 0 Autograft MED-A Form Download NHL B-Cell Day 0 Allograft MED-A Form
Lymphomas - T-cell Non Hodgkins (NHL) Download NHL T-Cell Day 0 Autograft MED-A Form Download NHL T-Cell Day 0 Allograft MED-A Form
MDSs and MPNs - Myelodysplastic Syndromes (MDS) Download MDS Day 0 Autograft MED-A Form Download MDS Day 0 Allograft MED-A Form
MDSs and MPNs - Combined Myelodysplastic / Myeloproliferative (MDS/MPN) Download Combined MDS/MPN Day 0 Autograft MED-A Form Download Combined MDS/MPN Day 0 Allograft MED-A Form
MDSs and MPNs - Myeloproliferative Neoplasms (MPN) Download MPN Day 0 Autograft MED-A Form Download MPN Day 0 Allograft MED-A Form
Plasma Cell Disorders (PCD) inc Multiple Myeloma Download PCD Day 0 Autograft MED-A Form Download PCD Day 0 Allograft MED-A Form
Solid Tumours Download Solid Tumors Day 0 Autograft MED-A Form Download Solid Tumors Day 0 Allograft MED-A Form

MED-A Day 100 and Follow Up by Graft Type

Document autograft allograft
Day 100 Download Day 100 Autograft MED-A Form Download Day 100 Allograft MED-A Form
Follow Up Download Annual Follow Up Autograft MED-A Form Download Annual Follow Up Allograft MED-A Form

Additional MED-A Documents

Document Download
MED-A Forms Full Version Download MED-A Forms Full Version
Summary of MED-A changes (April 2016 onwards) Download Summary of MED-A changes (April 2016 onwards)

 

HSCT MED-B Forms

One of the two type-specific forms (Allograft or Autograft) must be submitted for each transplant. Additionally, at least one disease form must be submitted with each transplant.

Type-specific Forms

Autograft Download HSCT MED-B Autograft Form
Allograft Download HSCT MED-B Allograft Form

Disease-specific Forms

Acute Leukaemia Download AL MED-B Form
Amyloidosis Download Amyloidosis MED-B Form
Bone Marrow Failure Syndromes inc Aplastic Anaemia Download AA MED-B Form
CLL Download CLL MED-B Form
CML Download CML MED-B Form
Haemoglobinopathy Download Haemoglobinopathy MED-B Form
Inherited Disorders Download Inherited Disorders MED-B Form
Juvenile Idiopathic Arthritis (JIA) Download JIA MED-B Form
Lymphoma Download Lymphoma MED-B Form
MDS Download MDS MED-B Form
MDS/MPN (e.g. CMML, JMML) Download MDS/MPN MED-B Form
MPN Download MPN MED-B Form
Multiple Sclerosis Download MS MED-B Form
Plasma Cell Disorders inc Multiple Myeloma Download PCD MED-B Form
Solid Tumours Download Solid Tumors MED-B Form
Systemic Lupus Erithematosus (SLE) Download SLE MED-B Form
Systemic Sclerosis Download Systemic Sclerosis MED-B Form

Additional Forms

Total Body Irradiation Download Total Body Irradiation Form

 

Clinical Manuals & Reference Documents

Document Download
MED-AB Forms Manual  Download MED-AB Forms Manual 
Cellular Therapy Manual Download Cellular Therapy Manual
Donor Outcome Manual Download Donor Outcome Manual
DISMCLFD List of Disease Classifications Download DISMCLFD List of Disease Classifications
DISMCLFD List of Disease Classifications (xls) Download DISMCLFD List of Disease Classifications (xls)
MED-AB List of Drug Names and Synonyms Download MED-AB List of Drug Names and Synonyms
Definitions for Disease Status and Response by Disease (xls) Download Definitions for Disease Status and Response by Disease (xls)
Definitions for Disease Status and Response by Disease Download Definitions for Disease Status and Response by Disease
NIH-defined GvHD Download NIH-defined GvHD
IDWP - Definitions of Infectious Diseases and Complications After SCT Download IDWP - Definitions of Infectious Diseases and Complications After SCT

 

Cellular Therapy Forms

Document Download
Cellular Therapy Pre-Infusion Registration Form Download Cellular Therapy Pre-Infusion Registration Form
Cellular Therapy Day 0 Form Download Cellular Therapy Day 0 Form
Cellular Therapy Day 100, 6M and Annual Follow Up Form Download Cellular Therapy Day 100, 6M and Annual Follow up Form

 

Donor Outcome Forms

Document Download
Donor Outcome Forms Download Donor Outcome Forms